Overview

This trial is active, not recruiting.

Conditions smoking, smoking cessation, nicotine dependence
Treatments counseling from wtql, financial incentive to participate
Phase phase 4
Sponsor University of Wisconsin, Madison
Start date April 2013
End date March 2016
Trial size 1962 participants
Trial identifier NCT02713594, 2013-0056 (400025710)

Summary

The study is designed to test the hypotheses that financial incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to BadgerCare Plus (Medicaid) smokers as part of their health care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Placebo Comparator)
The description of the service components that all participants will receive are: WTQL (Wisconsin Tobacco Quit Line) coaching consisting of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation. (If medically cleared) an 8-week supply of nicotine patches using standard dosing protocols (prescribed by patient's primary care provider) A follow up urine cotinine test at their clinic (at 6 months from enrollment) Participants randomized to this condition will receive financial incentives for them to participate in the biochemical verification visits at baseline and 6 months. They receive no other incentives.
counseling from wtql
WTQL coaching and encouragement to see their health care provider to obtain Medicaid-approved medications to help them quit
(Experimental)
The description of the service components that all participants will receive are: WTQL coaching consisting of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation. (If medically cleared) an 8-week supply of nicotine patches using standard dosing protocols (prescribed by patient's primary care provider) One follow up urine cotinine test at their clinic (at 6 months from enrollment) Participants randomized to the incentive condition will receive financial incentives for them to participate in the biochemical verification visits (baseline and 6 months) plus incentives to participate in treatment calls and a bonus incentive for abstinence at the 6 month follow-up visit.
counseling from wtql
WTQL coaching and encouragement to see their health care provider to obtain Medicaid-approved medications to help them quit
financial incentive to participate
Financial incentive provided for participation in WTQL coaching and for achieving biochemically-confirmed abstinence at the 6 month time point

Primary Outcomes

Measure
Abstinence from smoking
time frame: Measured 6 months after enrollment at follow-up assessment

Secondary Outcomes

Measure
Engagement in treatment
time frame: Measured 6 months after enrollment at follow-up assessment
Cost-effectiveness
time frame: Measured 6 months after enrollment

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - enrollment in Wisconsin Medicaid (BadgerCare Plus) - resides in study area (one of 25 counties) - 18 or older - English or Spanish speaking - has smoked daily (at least 5 cigarettes each day) over the last week - willingness to attend visits at his/her PCC (primary care clinic) or go to a testing site at baseline and 6 months (2 times over a 6 month period), provide urine samples or participate in exhaled carbon monoxide testing, and complete follow-up phone calls from the WTQL - willingness to inform the WTQL as to any change in address, phone number, clinic attended, or health plan. Exclusion Criteria: - not enrolled in Wisconsin Medicaid (BadgerCare Plus) - not reside in study area - less than 18 years of age - not English or Spanish speaking - does not smoke daily (at least 5 cigarettes each day) over the last week - not willing to attend visits at his/her PCC (primary care clinic) or alternative testing site at baseline and 6 months (2 times over a 6 month period), provide urine or exhaled carbon monoxide samples, and complete follow-up phone calls. - not willing to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.

Additional Information

Official title Wisconsin Tobacco Quit Line Centers for Medicaid Services Striving To Quit Evaluation Project
Principal investigator Timothy b Baker, PhD
Description Previous research on providing incentives for healthy behaviors has shown that financial incentives can increase treatment participation and boost outcomes when they are tied to participation in evidence based treatments. However, most of this research has been done in laboratory settings and in relatively small clinical trials. This study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to Wisconsin BadgerCare Plus (Medicaid) smokers as part of their health care. If successful, this treatment approach could be used more broadly to reduce the considerable financial and personal costs associated with smoking-related disease. Participants in the study are randomized to receive no incentive for participation in treatment and successful quitting or incentives.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.